The clearance covers tests made by the firm's joint venture for manufacturing, CoSara Diagnostics, in its facility in Ranoli, India.
In PNAS this week: analysis of extensively drug-resistant Mycobacterium tuberculosis strain, regulation of obesity-linked gene, and more.
The company said its test is faster, more precise, and cheaper than the current gold standard Cepheid GeneXpert test.
The Times of India reports on a pilot study that used genomic testing to determine whether patients had drug-resistant tuberculosis.
UK researchers said they are developing a commercial test that could enable sensitive detection of tuberculosis DNA in blood and provide an option to broaden screening.
The project, called Seq&Treat, will be implemented in Brazil, China, Georgia, India, and South Africa starting in October.
In PLOS this week: genes and pathways linked to multiple sclerosis, Salmonella enterica diversity in reptiles, and more.
Based on PCR technology acquired from Hain Diagnostics, the test and platform enable rapid detection of TB, as well as assessment of antibiotic resistance.
The partners inked a licensing deal to market and distribute TGen's DeepChek-TB as a compact, portable, and affordable diagnostic model for physician use.
In PLOS this week: population genetics of region with high Burkitt lymphoma rates, analysis of Brazilian Chikungunya virus strains, and more.
Nature News reports that gene therapy approaches are tackling sickle cell disease, but that the cost of treatment is a concern.
The Washington Post reports that a US Senate committee voted this week to approve the nomination of Stephen Hahn to lead the Food and Drug Administration.
One gene regulates hundreds of others to influence facial development, according to New Scientist.
In Nature this week: resources for single-cell analysis, little overlap in the microRNAs used by Salmonella and Shigella to infect host cells, and more.